Effectiveness of interventions to improve adherence to antidepressant medication in patients with depressive disorders: a cluster randomized controlled trial.

Aim: To assess the effectiveness of two interventions of knowledge transfer and behavior modification to improve medication adherence in patients with depressive disorders. Methods: An open, multicenter, three-arm clinical trial with random allocation by cluster to usual care or to one of the two interventions. The intervention for psychiatrists (PsI) included an educational program based on a patient-centered care model. The intervention for patients and relatives (PtI) included a collaborative care program plus a reminder system that works using an already available medication reminder application. The primary outcome was patient adherence to antidepressant treatment assessed through the Sidorkiewicz Adherence Instrument. Secondary measures were depression severity, comorbid anxiety and health-related quality of life. Mixed regression models with repeated measures were used for data analysis. Results: Ten psychiatrists and 150 patients diagnosed with depressive disorder from eight Community Mental Health Units in the Canary Islands (Spain) were included. Compared with usual care, no differences in long-term adherence were observed in either group PsI or PtI. The PsI group had significantly improved depression symptoms (B = -0.39; 95%CI: -0.65, -0.12; p = 0.004) during the follow-up period. The PtI group presented improved depression symptoms (B = -0.63; 95%CI: -0.96, -0.30; p < 0.001) and mental quality of life (B = 0.08; 95%CI: 0.004, 0.15; p = 0.039) during the follow-up period. Conclusion: The assessed interventions to improve adherence in patients with depressive disorder were effective for depression symptoms and mental quality of life, even over the long term. However, no effect on antidepressant adherence was observed.

Percutaneous ethanol injection in thyroid nodular pathology and metastatic cervical adenopathies: A systematic review, meta-analysis and economic evaluation.

BACKGROUND: Percutaneous ethanol injection (PEI) has been shown to be a valuable treatment for thyroid nodular pathology and metastatic cervical adenopathies. OBJECTIVE: To evaluate the effectiveness, safety, and cost-effectiveness of PEI in thyroid nodular pathology and metastatic cervical adenopathies. METHODS: A systematic review (SR) using meta-analysis was conducted on the effectiveness and safety of PEI. A SR on cost-effectiveness was also performed. The SRs were conducted according to the methodology developed by the Cochrane Collaboration with reporting in accordance with the PRISMA statement. A cost-minimization analysis was carried out using a decision tree model. Assuming equal effectiveness between two minimally invasive techniques (PEI and radiofrequency ablation (RFA)), the model compared the costs of the alternatives with a horizon of six months and from the perspective of the Spanish National Health System. RESULTS: The search identified three RCTs (n=157) that evaluated PEI versus RFA in patients diagnosed with benign thyroid nodules: ninety-six patients with predominantly cystic nodules and sixty-one patients with solid nodules. No evidence was found on other techniques or thyroid nodular pathology. No statistically significant differences were observed between PEI and RFA in volume reduction (%), symptom score, cosmetic score, therapeutic success and major complications. No economic evaluations were identified. The cost-minimization analysis estimated the cost per patient of the PEI procedure at €326 compared to €4781 for RFA, which means an incremental difference of -€4455. CONCLUSIONS: There are no differences between PEI and RFA regarding their safety and effectiveness, but the economic evaluation determined that the former option is cheaper.

[Scalp cooling for the prevention of chemotherapy-induced alopecia: systematic review and meta-analysis.] / Enfriamiento del cuero cabelludo para la prevención de la alopecia secundaria a quimioterapia: revisión sistemática y metanálisis.

OBJECTIVE: Alopecia is one of the most common adverse effects of chemotherapy, having a significant impact on the quality of life of patients who suffer from it. Among the interventions available for its prevention, scalp cooling (SC) is the most widely used. The aim of this study was to assess the efficacy and safety of the use of SC systems during chemotherapy sessions for the prevention or the reduction of the extent of chemotherapy-induced alopecia. METHODS: A systematic review of the literature published up to November 2021 was carried out. Randomized clinical trials were selected. The main outcome measure was alopecia (hair loss>50%) during and after chemotherapy treatment. When possible, a quantitative synthesis of the results was performed through meta-analysis using the Stata v.15.0 software. The risk ratio (RR) of the variable alopecia, was estimated using a random effects model following the Mantel-Haenszel method. Statistical heterogeneity of the results was evaluated graphically and through the test of heterogeneity χ2 and the Higgins I2 statistic. Sensitivity analyses and subgroup analyses were performed. RESULTS: 13 studies were included, with a total of 832 participants (97.7% women). In most studies, the main chemotherapy treatment applied was anthracyclines or the combination of anthracyclines and taxanes. The results obtained indicate that SC prevents alopecia (loss>50%) by 43% compared to the control group (RR=0.57; 95% CI=0.46 to 0.69; k=9; n=494; I2=63.8%). No statistically significant difference was found between the efficacy of automated and non-automated cooling systems (P=0.967). No serious short- or medium-term adverse events related to SC were recorded. CONCLUSIONS: The results suggest that scalp cooling contributes to the prevention of chemotherapy-induced alopecia.

OBJETIVO: La alopecia es uno de los efectos adversos más comunes de la quimioterapia, con un impacto importante sobre la calidad de vida de los/las pacientes que la padecen. Entre las intervenciones disponibles para su prevención, el enfriamiento del cuero cabelludo (ECC) es la que cuenta con un uso más extendido. El objetivo de este estudio fue evaluar la eficacia y la seguridad del uso de sistemas de ECC durante las sesiones de quimioterapia para la prevención o reducción de la extensión de la alopecia secundaria a la quimioterapia. METODOS: Se llevó a cabo una revisión sistemática de la literatura publicada hasta noviembre de 2021. Se seleccionaron ensayos clínicos aleatorizados. La medida de resultado principal fue la alopecia (pérdida de cabello superior al 50%) durante y posteriormente al tratamiento de quimioterapia. Cuando fue posible, se realizó síntesis cuantitativa de los resultados mediante metanálisis con el programa Stata v.15.0. Se estimó el riesgo relativo (RR) de la variable alopecia, utilizando un modelo de efectos aleatorios siguiendo el método de Mantel-Haenszel. La heterogeneidad estadística de los resultados se evaluó gráficamente y mediante el test de la χ2 y el estadístico I2 de Higgins. Se realizaron análisis de sensibilidad y análisis de subgrupos. RESULTADOS: Se incluyeron 13 estudios con un total de 832 participantes (97,7% de mujeres). En la mayoría de los estudios, los agentes quimioterapéuticos principales aplicados fueron las antraciclinas o la combinación de antraciclinas y taxanos. Los resultados obtenidos indican que el ECC reduce la aparición de la alopecia un 43% frente al grupo control (RR=0,57; IC95%=0,46 a 0,69; k=9; n=494; I2=63,8%). No se encontró una diferencia estadísticamente significativa entre la eficacia de sistemas de enfriamiento automatizados y no automatizados (P=0,967). No se registraron eventos adversos graves a corto o medio plazo relacionados con el ECC. CONCLUSIONES: Los resultados sugieren que el ECC contribuye a prevenir la alopecia secundaria a la quimioterapia.

Enfriamiento del cuero cabelludo para la prevención de la alopecia secundaria a quimioterapia: revisión sistemática y metanálisis / Scalp cooling for the prevention of chemotherapy-induced alopecia: systematic review and meta-analysis

Fundamentos: La alopecia es uno de los efectos adversos más comunes de la quimioterapia, con un impacto importante sobrela calidad de vida de los/las pacientes que la padecen. Entre las intervenciones disponibles para su prevención, el enfriamiento delcuero cabelludo (ECC) es la que cuenta con un uso más extendido. El objetivo de este estudio fue evaluar la eficacia y la seguridaddel uso de sistemas de ECC durante las sesiones de quimioterapia para la prevención o reducción de la extensión de la alopeciasecundaria a la quimioterapia. Métodos: Se llevó a cabo una revisión sistemática de la literatura publicada hasta noviembre de 2021. Se seleccionaron ensayosclínicos aleatorizados. La medida de resultado principal fue la alopecia (pérdida de cabello superior al 50%) durante y posteriormenteal tratamiento de quimioterapia. Cuando fue posible, se realizó síntesis cuantitativa de los resultados mediante metanálisis con elprograma Stata v.15.0. Se estimó el riesgo relativo (RR) de la variable alopecia, utilizando un modelo de efectos aleatorios siguiendoel método de Mantel-Haenszel. La heterogeneidad estadística de los resultados se evaluó gráficamente y mediante el test de la χ2 yel estadístico I2 de Higgins. Se realizaron análisis de sensibilidad y análisis de subgrupos. Resultados: Se incluyeron 13 estudios con un total de 832 participantes (97,7% de mujeres). En la mayoría de los estudios, losagentes quimioterapéuticos principales aplicados fueron las antraciclinas o la combinación de antraciclinas y taxanos. Los resultadosobtenidos indican que el ECC reduce la aparición de la alopecia un 43% frente al grupo control (RR=0,57; IC95%=0,46 a 0,69; k=9;n=494; I2=63,8%). No se encontró una diferencia estadísticamente significativa entre la eficacia de sistemas de enfriamiento auto-matizados y no automatizados (P=0,967). No se registraron eventos adversos graves a corto o medio plazo relacionados con el ECC...(AU)

Background: Alopecia is one of the most common adverse effects of chemotherapy, having a significant impact on the qualityof life of patients who suffer from it. Among the interventions available for its prevention, scalp cooling (SC) is the most widely used. The aim of this study was to assess the efficacy and safety of the use of SC systems during chemotherapy sessions for the preventionor the reduction of the extent of chemotherapy-induced alopecia.Methods: A systematic review of the literature published up to November 2021 was carried out. Randomized clinical trials were selected. The main outcome measure was alopecia (hair loss>50%) during and after chemotherapy treatment. When possible, a quantitative synthesisof the results was performed through meta-analysis using the Stata v.15.0 software. The risk ratio (RR) of the variable alopecia, was estimatedusing a random effects model following the Mantel-Haenszel method. Statistical heterogeneity of the results was evaluated graphically andthrough the test of heterogeneity χ2 and the Higgins I2 statistic. Sensitivity analyses and subgroup analyses were performed. Results: 13 studies were included, with a total of 832 participants (97.7% women). In most studies, the main chemotherapy treat-ment applied was anthracyclines or the combination of anthracyclines and taxanes. The results obtained indicate that SC preventsalopecia (loss>50%) by 43% compared to the control group (RR=0.57; 95% CI=0.46 to 0.69; k=9; n=494; I2=63.8%). No statisticallysignificant difference was found between the efficacy of automated and non-automated cooling systems (P=0.967). No serious short-or medium-term adverse events related to SC were recorded. Conclusions: The results suggest that scalp cooling contributes to the prevention of chemotherapy-induced alopecia.(AU)

Telemedicine for neurological diseases: A systematic review and meta-analysis.

BACKGROUND AND PURPOSE: The aim was to systematically review the effectiveness and safety of telemedicine combined with usual care (in-person visits) compared to usual care for the therapeutic management and follow-up assessment of neurological diseases. METHODS: The electronic databases MEDLINE, Embase, Web of Science and Cochrane Central Register of Controlled Trials were searched (June 2021). Randomized controlled trials (RCTs) on patients of any age with neurological diseases were considered. Two reviewers screened and abstracted data in duplicate and independently and assessed risk of bias using the Cochrane risk-of-bias tool for randomized trials (RoB 2). When possible, pooled effect estimates were calculated. RESULTS: Of a total of 3018 records initially retrieved, 25 RCTs (n = 2335) were included: 11 (n = 804) on stroke, four (n = 520) on Parkinson's disease, three (n = 110) on multiple sclerosis, two (n = 320) on epilepsy, one (n = 63) on dementia, one (n = 23) on spina bifida, one (n = 40) on migraine, one (n = 22) on cerebral palsy and one (n = 433) on brain damage. Types of telemedicine assessed were online visits (11 studies), tele-rehabilitation (seven studies), telephone calls (three), smartphone apps (two) and online computer software (two). The evidence was quite limited except for stroke. Compared to usual care alone, telemedicine plus usual care was found to improve depressive symptoms, functional status, motor function, executive function, generic quality of life, healthcare utilization and healthy lifestyle in patients in post-stroke follow-up. CONCLUSIONS: Well-designed and executed RCTs are needed to confirm our findings on stroke and to have more scientific evidence available for the other neurological diseases.

Barriers and Facilitating Factors of Adherence to Antidepressant Treatments: An Exploratory Qualitative Study with Patients and Psychiatrists.

This study examines the experiences and expectations of patients with depressive disorders regarding the disease and different antidepressants, as well as examining the barriers and facilitating factors that could affect their adherence to medications. An exploratory qualitative study was carried out. The study involved two focus groups made up of patients and caregivers and six semi-structured interviews with psychiatrists. In both cases, the participants were selected by intentional theoretical sampling, seeking maximum significance variation of social types. Prejudice about the side effects of medication was relevant. The importance of patients being well informed about the disease/treatments was noteworthy. The stigmatization of antidepressants by patients was identified as a barrier to medication adherence. The involvement of family members and the motivation of patients to be actively involved in the process to recover from the disease were identified as facilitating factors. The work carried out suggests the need for patients to have rigorous information about the disease/treatment to reduce the possible prejudices generated by beliefs. Maintaining greater contact and monitoring of patients/caregivers to help therapeutic adherence in patients with depressive disorders was also identified as being of great importance.

Molecular Biomarkers for the Detection of Clinically Significant Prostate Cancer: A Systematic Review and Meta-analysis.

Context: Prostate cancer (PCa) is the second most common type of cancer in men. Individualized risk stratification is crucial to adjust decision-making. A variety of molecular biomarkers have been developed in order to identify patients at risk of clinically significant PCa (csPCa) defined by the most common PCa risk stratification systems. Objective: The present study aims to examine the effectiveness (diagnostic accuracy) of blood or urine-based PCa biomarkers to identify patients at high risk of csPCa. Evidence acquisition: A systematic review of the literature was conducted. Medline and EMBASE were searched from inception to March 2021. Randomized or nonrandomized clinical trials, and cohort and case-control studies were eligible for inclusion. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool. Pooled estimates of sensitivity, specificity, and area under the curve were obtained. Evidence synthesis: Sixty-five studies (N = 34 287) were included. Not all studies included prostate-specific antigen-selected patients. The pooled data showed that the Prostate Health Index (PHI), with any cutoff point between 15 and 30, had sensitivity of 0.95-1.00 and specificity of 0.14-0.33 for csPCa detection. The pooled estimates for SelectMDx test sensitivity and specificity were 0.84 and 0.49, respectively. Conclusions: The PHI test has a high diagnostic accuracy rate for csPCa detection, and its incorporation in the diagnostic process could reduce unnecessary biopsies. However, there is a lack of evidence on patient-important outcomes and thus more research is needed. Patient summary: It has been possible to verify that the application of biomarkers could help detect prostate cancer (PCa) patients with a higher risk of poorer evolution. The Prostate Health Index shows an ability to identify 95-100 for every 100 patients suffering from clinically significant PCa who take the test, preventing unnecessary biopsies in 14-33% of men without PCa or insignificant PCa.

Effectiveness of interventions to improve medication adherence in adults with depressive disorders: a meta-analysis.

BACKGROUND: Non-adherence to medication is a major obstacle in the treatment of depressive disorders. We systematically reviewed the literature to evaluate the effectiveness of interventions aimed at improving adherence to medication among adults with depressive disorders with emphasis on initiation and implementation phase. METHODS: We searched Medline, EMBASE, The Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, Social Science Citation Index and Science Citation Index for randomized or non-randomized controlled trials up to January 2022. Risk of bias was assessed using the criteria of the Cochrane Collaboration. Meta-analyses, cumulative and meta-regression analyses for adherence were conducted. RESULTS: Forty-six trials (n = 24,324) were included. Pooled estimate indicates an increase in the probability of adherence to antidepressants at 6 months with the different types of interventions (OR 1.33; 95% CI: 1.09 to 1.62). The improvement in adherence is obtained from 3 months (OR 1.62, 95% CI: 1.25 to 2.10) but it is attenuated at 12 months (OR 1.25, 95% CI: 1.02 to 1.53). Selected articles show methodological differences, mainly the diversity of both the severity of the depressive disorder and intervention procedures. In the samples of these studies, patients with depression and anxiety seem to benefit most from intervention (OR 2.77, 95% CI: 1.74 to 4.42) and collaborative care is the most effective intervention to improve adherence (OR 1.88, 95% CI: 1.40 to 2.54). CONCLUSIONS: Our findings indicate that interventions aimed at improving adherence to medication among adults with depressive disorders are effective up to six months. However, the evidence on the effectiveness of long-term adherence is insufficient and supports the need for further research efforts. TRIAL REGISTRATION: International Prospective Register for Systematic Reviews (PROSPERO) number: CRD42017065723 .

Prognostic Impact of Sarcopenia in Patients with Advanced Prostate Carcinoma: A Systematic Review.

Prostate cancer (PCa) is the second most common cancer in men and the fifth leading cause of death from cancer. The possibility of sarcopenia being a prognostic factor in advanced PCa patients has recently become a subject of interest. The aim of the present study was to evaluate the prognostic value of sarcopenia in advanced prostate carcinoma. A systematic review was conducted in Medline, EMBASE, and Web of Science (March, 2021). The quality of studies was assessed using the Quality in Prognosis Studies tool. Meta-analyses for overall, cancer-specific, and progression-free survival were performed. Nine studies (n = 1659) were included. Sarcopenia was borderline associated with a shorter overall survival (HR = 1.20, 95% CI: 1.01, 1.44, P = 0.04, I2 = 43%) but was significantly associated with progression-free survival (HR = 1.61, 95% CI: 1.26, 2.06, P < 0.01; k = 3; n = 588). Available evidence supports sarcopenia as an important prognostic factor of progression-free survival in patients with advanced PCa. However, sarcopenia has a weak association with a shorter overall survival. The evidence on the role of sarcopenia in prostate-cancer-specific survival is insufficient and supports the need for further research. Patient summary: The literature was reviewed to determine whether the loss of muscle mass (sarcopenia) affects the survival in patients with advanced PCa. Patients with advanced PCa and sarcopenia were found to have a shorter progression-free survival (the length of time during and after treatment of a cancer that the patient lives with the disease but it does not get worse), but sarcopenia did not have much influence on the overall survival and cancer-specific survival (the length of time from either the date of diagnosis or the start of treatment to the date of death due to the cancer).

Aplicaciones móviles para mejorar la adherencia a la medicación: revisión y análisis de calidad / Mobile applications to improve drug adherence: Review and quality analysis

Objetivo: Revisar las aplicaciones móviles en español para mejorar la adherencia farmacológica y evaluar sus características y calidad con el fin de identificar aplicaciones de alta calidad. Médoto: Se ha hecho una revisión siguiendo un procedimiento por pasos similar a una revisión sistemática de la literatura. La fuente de los datos han sido plataformas de distribución digital de aplicaciones móviles Apple Apps Store y Google Play Store. Se han seleccionado aquellas aplicaciones dirigidas a apoyar la autogestión de los medicamentos, capaces de generar recordatorios, en español, actualizadas en los últimos 2 años y gratuitas. Los análisis de las aplicaciones se han hecho según un conjunto de características consideradas deseables y evaluación de la calidad con la herramienta Mobile App Rating Scale. Resultados: De 708 aplicaciones, se seleccionaron 3. Las aplicaciones Medisafe y Mytherapy presentaron el 89% y el 78% de las características deseables, respectivamente. La aplicación de Sergio Licea presentó el 56%. La mayor puntuación global de calidad la obtuvo MyTherapy (3,79/5; RIQ: 3-4), seguida de Medisafe (3,72/5; RIQ: 3-4) y, por último, Sergio Licea (2,87/5; RIQ: 2-4). La valoración de la calidad es coincidente con la hecha por los usuarios. Hay muchas aplicaciones disponibles, sin embargo, la mayoría no cumplieron los criterios de selección establecidos. Conclusiones: Através de un proceso sistemático por pasos, identificamos la aplicación de mayor calidad en español para que sea probada en un estudio futuro, que proporcionará evidencia sobre el uso de una intervención multicomponente para mejorar la adherencia a la medicación.(AU)

Objective: To review the mobile apps in the Spanish market to improve adherence to medications and evaluate their characteristics and quality to identify high-quality applications. Method: A review was carried out following a stepwise procedure similar to a systematic review of the scientific literature. Apple Apps Store and Google Play Store mobile application digital distribution platforms. Applications aimed at supporting self-management of treatment, which generate reminders, in Spanish, updated in the last 2 years and free. We evaluate the applications according to a set of characteristics considered desirable and the quality with the Mobile App Rating Scale tool. Results: Out of 708 applications, 3 applications were selected. The Medisafe and Mytherapy applications had 89% and 78% of the desirable characteristics, respectively. Sergio Licea's application only had 56%. The highest global quality score was obtained by the MyTherapy application (3.79/5, IQR: 3-4), followed by Medisafe (3.72/5, (IQR: 3-4) and, finally, Sergio Licea (2.87/5, IQR: 2-4). The quality assessment coincides with the user assessment. There are many available applications, however, most did not meet the selection criteria. Conclusions: A systematic stepwise process was able to identify the quality application to be tested in a future study that will provide evidence on the use of a multicomponent inter.(AU)

[Mobile applications to improve drug adherence: Review and quality analysis]. / Aplicaciones móviles para mejorar la adherencia a la medicación: revisión y análisis de calidad.

OBJECTIVE: To review the mobile apps in the Spanish market to improve adherence to medications and evaluate their characteristics and quality to identify high-quality applications. METHOD: A review was carried out following a stepwise procedure similar to a systematic review of the scientific literature. Apple Apps Store and Google Play Store mobile application digital distribution platforms. Applications aimed at supporting self-management of treatment, which generate reminders, in Spanish, updated in the last 2 years and free. We evaluate the applications according to a set of characteristics considered desirable and the quality with the Mobile App Rating Scale tool. RESULTS: Out of 708 applications, 3 applications were selected. The Medisafe and Mytherapy applications had 89% and 78% of the desirable characteristics, respectively. Sergio Licea's application only had 56%. The highest global quality score was obtained by the MyTherapy application (3.79/5, IQR: 3-4), followed by Medisafe (3.72/5, (IQR: 3-4) and, finally, Sergio Licea (2.87/5, IQR: 2-4). The quality assessment coincides with the user assessment. There are many available applications, however, most did not meet the selection criteria. CONCLUSIONS: A systematic stepwise process was able to identify the quality application to be tested in a future study that will provide evidence on the use of a multicomponent intervention to improve medication adherence.

Framing the process in the implementation of care for people with generalized anxiety disorder in primary care: a qualitative evidence synthesis.

BACKGROUND: Generalized anxiety disorder (GAD) is one of the most common mental disorders in primary care (PC). GAD has low remission and high relapse rates over long follow-up periods. Qualitative evidence was synthesized to understand the implementation of care and treatment options for people with GAD in PC. METHODS: Research published from 2008 to September 2020 was searched in five databases (MEDLINE, EMBASE, CINAHL, WOS and PsycArticles). Studies that used qualitative methods for data collection and analysis to investigate the implementation of care and treatment options for people with GAD in PC and outpatient settings were included. Non-qualitative studies, mixed methods studies that did not separately report qualitative findings and studies in languages other than English or Spanish were excluded. We used the Confidence in the Evidence from Reviews of Qualitative Research (CERQual) framework to assess the overall confidence in the findings. RESULTS: The results with a moderate level of confidence showed that the trajectory of care for people with GAD in PC and outpatient settings is long and fluctuates over time, involving multiple difficulties in accessing and maintaining initial treatment or successive treatment options. In addition, there are wide variations in the preferences for and acceptability of different treatment options. The results with a high level of confidence indicated that more information on GAD and its treatment options is needed for PC practitioners, GAD patients and their carers. The results with a low level of confidence suggested that patients use antidepressants for longer than recommended and that the interruption of treatment is not usually planned. CONCLUSIONS: Initial resistance to new treatments among people with GAD can make access and adherence to treatment difficult. Improving care may require patients to be informed of possible trajectories in stepped care pathways before the initiation of treatment so they are aware that they may need to try a number of options until the most effective treatment for them is found. Increased awareness of and information materials on GAD may facilitate both appropriate diagnosis and long-term care.

Multicomponent Interventions for the Prevention of Delirium in Hospitalized Older People: A Meta-Analysis.

OBJECTIVES: To comprehensively assess the effects of multicomponent interventions for prevention of delirium in hospitalized older people. DESIGN: Systematic review with meta-analysis following Preferred Reporting Items for Systematic Reviews and Meta-Analyses methods. PARTICIPANTS: All randomized controlled trials were included. Included studies were conducted in hospitalized older people (aged ≥65 years). MEASUREMENTS: The electronic databases MEDLINE, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials were consulted (search date: 2015 to March 2019). Predefined criteria were used to determine inclusion of studies and to assess their methodologic quality. RESULTS: From 1,250 records identified, 10 randomized controlled trials were included (n = 2,850: 1355 medical patients, 1,243 surgical, and 160 intensive care unit). The multicomponent interventions, compared with usual care, reduced the incidence of delirium (risk ratio (RR) = 0.62; 95% confidence interval (CI) = 0.54-0.72; I2 = 0%; k = 10; n = 2,758), duration of delirium (RR = -1.18; 95% CI = -1.95 to -0.40; I2 = 45%; k = 6; n = 276), severity of delirium (standard mean difference = -0.98; 95% CI = -1.46 to -0.49; I2 = 0%; k = 3; n = 82), and pressure ulcers (RR = 0.48; 95% CI = 0.26-0.88; I2 = 0%; k = 2; n = 457). CONCLUSIONS: This meta-analysis suggests that multicomponent interventions to prevent delirium are effective in decreasing its incidence, duration, and severity; as well as the incidence of pressure ulcers in hospitalized older people. Therefore, multicomponent interventions hold great promise to impact in the most important and prevalent conditions affecting fragile older people during hospitalization.

Pharmacologic interventions for prevention of delirium in hospitalized older people: A meta-analysis.

INTRODUCTION: To comprehensively assess the effects of pharmacologic interventions for prevention of delirium in hospitalized older people. MATERIALS AND METHODS: A systematic review with meta-analysis following Preferred Reporting Items for Systematic reviews and Meta-Analyses methodology was performed. Hospitalized people aged 65 and older, recruited to randomized controlled clinical trials. The electronic databases MEDLINE, EMBASE, WOS and Cochrane Central Register of Controlled Trials were consulted (March 2019). Predefined criteria were used to determine inclusion of studies and to assess their methodologic quality. RESULTS: 1855 records were identified in the database, and after removing the duplicates, the titles and abstracts evaluated were 1250 records. Finally, 25 randomized controlled trials contributed to meta-analysis (n = 5820): 1 anti-epileptics (n = 697), 2 anti-inflammatories (n = 615), 4 antipsychotics (n = 1193), 2 cholinesterase inhibitors (n = 87), 13 hypnotics/sedatives (n = 2909), 1 opioids (n = 52), 1 psychostimulants/nootropics (n = 81), 1 yokukansan (n = 186). Olanzapine (RR = 0.36; 95 %CI: 0.24, 0.52; k = 1; n = 400), rivastigmine (RR = 0.36; 95 %CI: 0.15, 0.87; k = 1; n = 62), dexmedetomidine (RR = 0.52; 95 %CI: 0.38, 0.71; I²â€¯= 55 %; k = 6; n = 2084), and ramelteon (RR = 0.09; 95 %CI: 0.01, 0.64; k = 1; n = 65) reduced the incidence of delirium compared to placebo/usual care. Only dexmedetomidine was also associated with a shorter duration of delirium (0.70 days reduction) and a lower consumption of psychotropic drugs (48 %). No effect was found in mortality, adverse events, urinary tract infections or post-operative complications. CONCLUSIONS: This meta-analysis suggests that dexmedetomidine is effective in reducing the incidence and duration of delirium in hospitalized older patients. Individual studies reveal effects of ramelteon, olanzapine and rivastigmine on the incidence of delirium but the evidence is insufficient to draw a robust conclusion.

Relationship between glycemic control and chronic obstructive pulmonary disease in patients with type 2 diabetes: A nested case-control study.

AIMS: To evaluate the relationship between glycemic control and plasma glycated hemoglobin (HbA1c) levels in patients with type 2 diabetes mellitus (T2D) and the risk of chronic obstructive pulmonary disease (COPD). METHODS: We conducted a population-based, retrospective, nested, case-control study involving 124,876 patients with DM2 from the Canary Islands, Spain. From the cohort, we selected all COPD cases and, for each case, five control subjects who were COPD free. We analyzed the association between glycemic control, HbA1c level and incident COPD. RESULTS: A total of 1320 incidence cases of COPD (1.06%) were identified and matched individually with 6600 controls according to age and sex. After multivariate adjustment, the COPD risk increased among patients with poor glycemic control compared to patients with good glycemic control [HbA1c levels <7% (53 mmol/mol)] (OR 1.18; 95% CI: 1.03-1.36). In comparison with patients exhibiting HbA1c levels <7% (53 mmol/mol), the risk of COPD was higher among people with HbA1c levels of 7-8% (53-64 mmol/mol) (OR 1.24; 95% CI: 1.05-1.47) and 8-9% (64-75 mmol/mol) (OR 1.31; 95% CI: 1.04-1.66). CONCLUSIONS: Poor glycemic control reveals a weak association with increased risk of COPD in T2D patients.

Effectiveness and cost-effectiveness of a multicomponent intervention to implement a clinical practice guideline for systemic lupus erythematosus: protocol for a cluster-randomized controlled trial.

BACKGROUND: Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease with significant potential morbidity and mortality. Substantial gaps have been documented between the development and dissemination of clinical practice guidelines (CPG) and their implementation in practice. The aim of this study is to assess the effectiveness and cost-effectiveness of a multi-component knowledge transfer intervention to implement a CPG for the management of SLE (CPG-SLE). METHODS: The study is an open, multicentre, controlled trial with random allocation by clusters to intervention or control. Clusters are four public university hospitals of the Canary Islands Health Service where rheumatologists are invited to participate. Patients diagnosed with SLE at least one year prior to recruitment are selected. Rheumatologists in intervention group receive a short educational group programme to both update their knowledge about SLE management according to CPG-SLE recommendations and to acquire knowledge and training on use of the patient-centred approach, a decision support tool embedded in the electronic clinical record and a quarterly feedback report containing information on management of SLE patients. Primary endpoint is change in self-perceived disease activity. Secondary endpoints are adherence of professionals to CPG-SLE recommendations, health-related quality of life, patient perception of their participation in decision making, attitudes of professionals towards shared decision making, knowledge of professionals about SLE and use of healthcare resources. Calculated sample size is 412 patients. Data will be collected from questionnaires and clinical records. Length of follow-up will be 18 months. Multilevel mixed models with repeated time measurements will be used to analyze changes in outcomes over time. Cost-effectiveness, from both social and healthcare services perspectives, will be analyzed by measuring effectiveness in terms of quality-adjusted life years gained. Deterministic and probabilistic sensitivity analyses are planned. DISCUSSION: Impact of CPGs in clinical practice could be improved by applying proven value interventions to implement them. The results of this ongoing trial are expected to generate important scientifically valid and reproducible information not only on clinical effectiveness but also on cost-effectiveness of a multi-component intervention for implementation of a CPG based on communication technologies for chronic patients in the hospital setting. TRIAL REGISTRATION: ClinicalTrial.gov NCT03537638 . Registered on 25 May 2018.

Subcutaneous implantable cardioverter-defibrillator in primary and secondary prevention of sudden cardiac death: A meta-analysis.

BACKGROUND: Subcutaneous implantable cardioverter-defibrillator (S-ICD) is gaining in popularity for primary and secondary prevention of sudden cardiac death. The objective was to evaluate the safety and clinical effectiveness of the S-ICD for prevention of sudden cardiac death compared to transvenous cardioverter-defibrillator (TV-ICD). METHODS: A systematic review with meta-analyses was performed. The electronic databases MEDLINE, EMBASE, SCI, and Cochrane Central Register of Controlled Trials were consulted in March 2018 with no restrictions on publication date. Predefined criteria were used to determine inclusion of studies and to assess their methodologic quality. RESULTS: Ten longitudinal-observational studies with comparison group presenting moderate methodologic flaws were included (N = 7820). The combination of results indicates that health-related quality of life is not significantly different between S-ICD and TV-ICD groups (Physical health: MD = 2.90; 95% CI = -3.88, 9.68/Mental health: MD = 0.13; 95% CI = -2.11, 2.37). Mortality occurred in 4.4% of S-ICD patients and 5.9% of TV-ICD patients died (OR = 0.79; 95% CI = 0.50, 1.24). The incidence of infections (OR = 1.79; 95% CI = 0.93, 3.43) and inappropriate shocks (OR = 1.28, 95% CI = 0.91, 1.78) is not significantly different between both groups. The S-ICD reduces complications related to electrodes/leads (OR = 0.13, 95% CI = 0.05, 0.29) and has lower electrodes/leads movement compared with TV-ICD (OR = 0.26; 95% CI 0.10, 0.67). In contrast, pneumothorax is more likely in TV-ICD than S-ICD (OR = 0.17; 95% CI = 0.03, 0.97). CONCLUSIONS: S-ICD reduces electrodes/leads movement, electrodes/leads related complications, and pneumothorax. Our study did not demonstrate a statistically significant difference in mortality, health-related quality of life, and infection rate between S-ICD and TV-ICD.

Effectiveness and cost-effectiveness of a multicomponent intervention to improve medication adherence in people with depressive disorders - MAPDep: a study protocol for a cluster randomized controlled trial.

PURPOSE: Depression is a widespread mental disorder which can be treated effectively. However, low adherence to antidepressants is very common. The study of medication adherence in depression (MAPDep study) assesses the effectiveness and cost-effectiveness of a multicomponent strategy to enhance adherence toward medications in patients with depression. INTERVENTION: The intervention is a multicomponent one consisting of an educational program for psychiatrists and/or a collaborative care program for patients and relatives, plus a reminder system that works through the use of an already available high-quality medication reminder application. STUDY DESIGN: MAPDep study is an open, multicenter, four-arm cluster randomized controlled trial. The clusters are mental health units where psychiatrists are invited to participate. The clusters are randomly allocated to one of the three interventions or to usual care (control arm). Patients (18-65 years of age) diagnosed with depressive disorder, those taking antidepressant medication for an existing diagnosis of depression, and mobile phone users are selected. In group 1, only patients and relatives receive intervention; in group 2, only psychiatrists receive intervention; and in group 3, patients/relatives and psychiatrists receive intervention. The primary outcome is adherence to the antidepressant drug. The calculated sample size is 400 patients. To examine changes across time, generalized linear mixed model with repeated measures will be used. A cost-effectiveness analysis will be conducted. The effectiveness measure is quality-adjusted life years. Deterministic sensitivity analyses are planned. CONCLUSION: MAPDep study aims to assess a multicomponent strategy to improve adherence toward medications in patients with depression, based not only on clinical effectiveness but also on cost-effectiveness. This methodology will enhance the transferability of the expected results beyond mental health services (patients and psychiatrists) to health care policy decision making. CLINICAL TRIAL IDENTIFIER: NCT03668457.

Stereoelectroencephalography for Refractory Epileptic Patients Considered for Surgery: Systematic Review, Meta-Analysis, and Economic Evaluation.

BACKGROUND: Stereoelectroencephalography (SEEG) has been shown to be a valuable tool for the anatomoelectroclinical definition of the epileptogenic zone (EZ) in patients with medically refractory epilepsy considered for surgery (RES patients). In Spain, many of those patients are not offered this diagnostic procedure. OBJECTIVE: To evaluate the effectiveness, safety, and cost-effectiveness of SEEG to define the EZ in RES patients compared to no SEEG intervention, ie, remaining with further antiepileptic drugs. METHODS: We undertook a systematic review with meta-analyses on the effectiveness and safety of SEEG. A cost-effectiveness analysis was conducted using a Markov model, which simulates the costs and health outcomes of individuals for a lifetime horizon from the perspective of the Spanish National Health Service. The effectiveness measure was quality-adjusted life years (QALYs). We ran extensive sensitivity analyses, including a probabilistic sensitivity analysis. RESULTS: The EZ was found in 92% of patients who underwent SEEG (95% confidence interval [CI]: 0.87-0.96); 72% were eligible for epilepsy surgery (95% CI: 0.66-0.78) and 33% were free of seizures after surgery (95% CI: 0.27-0.42). Of the patients who underwent surgery, 47% were free of seizures after surgery (95% CI: 0.37-0.58). Complications related to implantation and monitoring of SEEG and the subsequent intervention occurred in 1.3% of patients (95% CI: 0.01-0.02). In the base case analysis, SEEG led to higher QALYs and healthcare costs with an estimated incremental cost-effectiveness ratio of 10 368 EUR per QALY (95% CI: dominant-113 911), making the probability of cost-effectiveness between 75% and 88%. Further sensitivity analyses showed that the results of the study were robust. CONCLUSION: SEEG is a cost-effective technology in RES patients when compared to no SEEG intervention.

Platelet-rich plasma for the treatment of diabetic foot ulcers: A meta-analysis.

Foot ulcer is a major complication of diabetes mellitus and often precedes leg amputation. Among the different methods to achieve ulcer healing, the use of platelet-rich plasma, which is rich in multiple growth factors and cytokines and may have similarities to the natural wound healing process, is gaining in popularity. A systematic review with meta-analyses was performed to evaluate the safety and clinical effectiveness of platelet-rich plasma for the treatment of diabetic foot ulcers compared to standard treatment or any other alternative therapy. The electronic databases Medline, EMBASE, CINAHL, and Cochrane Central Register of Controlled Trials were consulted in March 2017 with no restrictions placed on the publication date. Predefined criteria were used to determine inclusion of studies and to assess their methodologic quality. Eight randomized clinical trials and two prospective longitudinal-observational studies with control group were included. Platelet-rich plasma treatment increased the likelihood of chronic wound healing (RR = 1.32; 95% CI: 1.11, 1.57, I2 = 15%) while the volume of the ulcer (MD = 0.12 cm2 ; 95% CI: 0.08, 0.16; p < 0.01; I2 = 0%) and time to complete wound healing (MD = -11.18 days; 95% CI: -20.69, -1.68; I2 = 53%) decreased. Regarding safety profile, platelet-rich plasma did not differ from standard treatment in terms of probability of occurrence of wound complications (RR = 0.57; 95% CI: 0.25, 1.28; I2 = 0%) or recurrences (RR = 2.76; 95% CI: 0.23, 33.36; p = 0.43; I2 = 82%) but it decreased the rate of adverse events (RR = 0.80; 95% CI: 0.66, 0.96; p = 0.02; I2 = 0%). Cumulative meta-analysis revealed that there is enough evidence to demonstrate a statistically significant benefit. However, studies included presented serious methodologic flaws. According to the results, platelet-rich plasma could be considered a candidate treatment for nonhealing of diabetic foot ulcers.